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Spotlight On: It’s Raining AI Devices as Regulatory Storm Reshapes Digital Health

1 day ago talkbio0Tagged 2025, Accountability, AI-enabled, clinical oversight, digital health regulation, digital mental health devices, draft guidance, EU, EU AI Act health, Generative AI, Health care facility, Medical Devices, Regulation, Software as a Medical Device, United States Food and Drug Administration

AI-enabled medical devices; digital health regulation 2025; FDA AI draft guidance; EU AI Act health; generative AI in healthcare; SaMD regulation; clinical oversight of AI; AI accountability in healthcare; digital mental health devices